LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000093)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00883873979020), received between Aug 16, 2019 and Feb 26, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 22, 2025Class IIOpen, Classified

   Due to required inspections not being performed on products/units that have gone through servicing.

   Z-2497-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE DEVICE'S DISPLAY WAS FROZEN ON STARTUP. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776950 ↗
• MalfunctionSep 30, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE WAS UNABLE TO COMPLETE A BOOT CYCLE. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510083 ↗
• MalfunctionSep 29, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS NOT COMPLETING THE BOOT UP PROCESS. AS A RESULT, DEFIBRILLATION THERAPY WOULD BE UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501829 ↗
• MalfunctionApr 6, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE IT LOCKED UP AT THE SELF-TEST SCREEN AND WOULD NOT COMPLETE A BOOT CYCLE. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9930359 ↗
• MalfunctionMar 11, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE THE BOOT UP CYCLE. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9820937 ↗
• MalfunctionFeb 10, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD NO POWER. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9690451 ↗
• MalfunctionAug 16, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND IT DID NOT DELIVER A SHOCK WHEN THEY INITIALLY ATTEMPTED TO DELIVER A SHOCK TO THE PATIENT. THEY WERE ABLE TO SUCCESSFULLY DELIVER A SHOCK TO THE PATIENT ON THE SECOND ATTEMPT. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8903852 ↗